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Trial Logistics Operations Manager

Swiftwater, Pennsylvania

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Responsibilities

The Trial Logistics Operations Manager (TLOM) will be responsible for assisting with activities and deliverables of the Sanofi Pasteur R&D Clinical Sample Management & Logistics (SML). S/he will be responsible to translate the clinical protocol in the best clinical supply chain for the Trial Related Material (TRM), along with all processes/training for collection processing clinical samples (e.g., serum, saliva, urine, nasal wash, NPS, PBMC, etc.) at the investigational sites. Management of the TRM requires the oversight of external partnerships

S/he is responsible for overseeing and managing all clinical samples logistics activities of assigned New Vaccines (NV) and Medical Affairs (MA) clinical projects.  The TLOM is accountable for the supply strategy to the investigational sites of any TRM that includes sample collection and processing items. S/he is accountable for the coordination of the transportation of samples to the testing laboratories.

The TLOM will work with senior management to identify operational “best practices” policies & procedures for clinical sample management logistics and assist with the implementation within the appropriate teams and at all respective investigational sites.

S/he partners with key stakeholders (R&D GO, GTOM, RTM, GCI, Procurement, CPMO, etc.), external vendors and Sanofi CSO/CSUs, to ensure clinical project delivery according to defined budget and planning, and with respect to quality standards.

The TLOM is a member of various Clinical teams.

Key Accountability:

Ensures optimal TRM supply to investigational sites, and optimizes sample transportation planning thru external partner oversight

  • Interprets TRM requirements from study protocol design and objectives with clinical team inputs
  • Defines along with R&D GO, GTOM, and RTM for sample labeling pre-requisites and sample transportation planning to respect study testing milestones
  • Develops the study TRM specifications, organizes pre-quotation meetings with the partner, and reviews the quotes with procurement support
  • Defines the TRM distribution specifications and strategy depending on participating countries and planned sites recruitment
  • Reviews quotes balancing savings and quality
  • Interfaces with the CPMO to release the Purchase Order
  • Organizes and leads the KOM with the partner to clarify the study objectives and planning, the expected deliverables according to the defined performance indicators and the defined budget
  • Coordinates TRM import/export permits according to countries specificities
  • Leads regular meetings with the Project Manager to adjust the plans according to study preparation progress and changes
  • Is accountable for clinical sample logistics budget, following payments in collaboration with CPMO till final reconciliation

Provides inputs on study documentation:

  • Protocol/SRMP/Monitoring plan/Operating Guidelines for sample management & logistics aspects

Presents study information and logistics status:

  • Participates in Investigator Meetings and CRA trainings
  • Provides study Sample Management Logistics/progress to the clinical team, R&D GO and any reports requested by the GTOM
  • Promotes efficient solutions to issues
  • Works with CRAs to resolve discrepancies related to sample management logistics discrepancies

Leads or Participates in transversal initiatives:

  • Assists with the identification of improvements of current sample management & logistic processes to ensure compliance of procedures to regulatory requirements and lead the creation and implementation of strategies, policies and procedures
  • Collaborate with customers within and outside of the SP R&D Clinical Sample Management & Logistics to ensure that customer needs are consistently met and the operational standards and practices within the function meet state-of-the-art industry expectations

Prepares for and responds to Audits/PAI/ Inspections:

  • Is accountable for up-to-date sample management logistics artifacts in EDMS  
  • Conducts regular TMF QC’s
  • Shares Audit/Inspection lessons learned with TLOM team and takes into consideration important observations

The Trial Logistics Operations Manager (TLOM) works in an international environment. S/he is charge of all the logistics aspects of (NV) and (MA) for Sanofi Pasteur sponsored trials.

S/he works with the clinical team members composed of representatives from all clinical functions under the co-leadership of the GTOM and Clinical Science representatives. S/he is a member of the Clinical Supply Chain (CSC) team led by the CSC Project Manager.

S/he operates with SP R&D organization based in US.

S/he oversees external partner activities (deliverables, performance and budget).

S/he is available for traveling (Investigator meetings, Team meetings)

The main challenges of the TLOM position are:

  • To secure efficient and continuous TRM for sample management & logistics to the investigational sites based in all regions, taking into account local regulations for import and export permit that are permanently evolving
  • To identify custom TRM demands and develop innovative solutions to allow for a successful study execution
  • To anticipate and mitigate sample management logistics risks (TRM, protocol amendments, planned versus actual recruitment rates, active and inactive sites)
  • To secure with the RTM the CRA monitoring on TRM and clinical human biological sample processing/collection
  • To provide comprehensive trial progress status to his/her internal and external customers, be able to negotiate and accept win-win solutions taking into account other functional area drivers staying aligned with company and clinical objectives, and respecting quality and performance indicators
  • To promote efficient solutions to routine or unexpected issues more or less complex in the field of the logistics area
  • To be able to respond to unexpected/urgent demand
  • To maintain blind to patient information until database lock for blinded trials

  • The Trial Logistics Operations Manager (TLOM) job function has wide responsibilities that apply to clinical trials conducted worldwide. S/he is accountable to select the correct TRM for clinical sample management & logistics (references, quantity) that will be used by the investigational sites according to the clinical protocol and site information, to respect the planned recruitment rates and the trial flow chart. S/he defines the best sample transportation strategy from sites to testing laboratories according to the testing planning.
  • S/he is accountable for CRA/site training on sample management & logistics domains, maintaining a follow-up by regular interactions with the RTMs.
  • S/he is responsible to propose process/template improvements.
  • S/he is responsible to develop training supports for the CRO-CRAs training and/or Investigator meetings

Financial dimension:

The Trial Logistics Operations Manager is responsible for a budget of 250 KE per year for the human biological sample TRM management

Human Resources dimensions:

No direct reports, but some transversal management

Statistical dimensions:

The Trial Logistics Operations Manager is in charge of 5-10 clinical trials per year. These clinical trials can cover 1-4 regions and several countries per region (1-6). S/he applies global SOPs specific to their functions

Qualifications:

  • M.Sc. +1yr experience
  • B.Sc. +3yr experience
  • +2 Clinical logistics experience preferred
  • Clinical trial knowledge
  • Knowledge of conducting vaccine clinical trials and clinical sample logistics
  • Project management and computer skills (Word, Excel, PowerPoint)
  • Good interpersonal and communication skills, interfacing with multiple functions and external partners
  • Good organizational and multitasking skills
  • Ability to work independently
  • Ability to work under pressure

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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